Submission Details
| 510(k) Number | K020257 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 24, 2002 |
| Decision Date | April 24, 2002 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
DATASCOPE'S 8FR. ALT B IAB; DATASCOPE'S PROFILE 8FR. ALT B IAB; DATASCOPE'S TRUE SHEATHLESS DL 9.5 FR. IAB; DATASCOPE'S
Apr 2002
Decision
90d
Days
Class 2
Risk
About This 510(k) Submission
K020257 is an FDA 510(k) clearance for the DATASCOPE'S 8FR. ALT B IAB; DATASCOPE'S PROFILE 8FR. ALT B IAB; DATASCOPE'S TRUE SHEATHLESS DL 9.5 FR. IAB; DATASCOPE'S, a System, Balloon, Intra-aortic And Control (Class II — Special Controls, product code DSP), submitted by Datascope Corp. (Fairfield, US). The FDA issued a Cleared decision on April 24, 2002, 90 days after receiving the submission on January 24, 2002. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3535.
Device Classification
| Product Code | DSP — System, Balloon, Intra-aortic And Control |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.3535 |
Manufacturer
Similar Devices — DSP System, Balloon, Intra-aortic And Control
All 161
K250542 · Arrow International, LLC
· Mar 2025
K232343 · Arrow International, LLC
· Aug 2023
K201112 · Arrow International, Inc.
· May 2020
K200634 · Arrow International, Inc.
· Apr 2020
K192238 · Arrow International, Teleflex
· Nov 2019
K190101 · Arrow International, Inc.
· Jun 2019
More from Datascope Corp.
View all
K190884
· GDW · Dec 2019
K181122
· DSP · May 2018
K172305
· DSP · Oct 2017
K163542
· DSP · Jan 2017
K151254
· DSP · Jul 2015